A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.
Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Fayette Street Clinics
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Current documented chart diagnosis of at least one chronic medical condition
- Received clinic services for a minimum of 3 months prior to study entry
- English-speaking
- Willing to use an effective form of birth control throughout the study if sexually active
Exclusion Criteria:
- History of a serious neurological disorder or head trauma with loss of consciousness
- Diagnosed with mental retardation or dementia
- Diagnosed with end stage organ disease
- Currently receiving chemotherapy and/or radiation treatment for cancer
- Received psychiatric hospitalization less than 3 months prior to study entry date
- Blind and/or deaf
- Pregnant
- Infected with HIV with a CD4 count under 350
- Diagnosis of AIDS
- Diagnosis of anorexia
- Problematic substance use, as defined by a mental health provider
- Psychiatric instability, as defined by a mental health provider
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
Participants will receive a self-management program for chronic illness
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Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
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Sem intervenção: Usaual Care
Usual Care; no additional intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Health-related self-efficacy and recovery orientation
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
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Medical illness self-management skills
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
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Social and communication skills during interactions with health care providers
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Medication use
Prazo: Measured throughout the study
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Measured throughout the study
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Neurocognition
Prazo: Measured at baseline
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Measured at baseline
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|
Substance abuse
Prazo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
Prazo: Measured at pre- and post-intervention
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Measured at pre- and post-intervention
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Amount and seriousness of related comorbidities
Prazo: Measured at pre- and post-intervention
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Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
Prazo: Measured throughout the study
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Measured throughout the study
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard W. Goldberg, PhD, University of Maryland, College Park
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Concessão/Contrato do NIH dos EUA)
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